PMID- 26497654 OWN - NLM STAT- MEDLINE DCOM- 20160818 LR - 20221207 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 15 DP - 2015 Oct 24 TI - Capecitabine and oxaliplatin combined with bevacizumab are feasible for treating selected Japanese patients at least 75 years of age with metastatic colorectal cancer. PG - 786 LID - 10.1186/s12885-015-1712-0 [doi] LID - 786 AB - BACKGROUND: Although number of elderly patients with metastatic colorectal cancer (mCRC) is rapidly increasing, this population is often underrepresented in clinical trials. Recently, a phase II trial demonstrated that capecitabine and oxaliplatin (XELOX) combined with bevacizumab XELOX plus bevacizumab was effective and well tolerated by elderly patients with mCRC who reside in Western countries. The aim of this study was to evaluate the safety and efficacy of XELOX plus bevacizumab for Japanese patients aged >/= 75 years with mCRC. METHODS: This prospective, open-label phase II trial recruited patients aged >/= 75 years with previously untreated mCRC between March 2010 and January 2012. Treatment consisted of 7.5 mg/kg of intravenous bevacizumab and 130 mg/m(2) of oxaliplatin on day 1 of each cycle combined with 2000 mg/m(2) of oral capecitabine per day on days 1-14 of each cycle. Treatment was repeated every 3 weeks until disease progression or termination of the study. The primary endpoint was progression-free survival; the secondary endpoints were toxicity, overall response rate, time-to-treatment failure, and overall survival. RESULTS: Thirty-six patients (male 58%; median age 78 years; colon cancer 67%) met all eligibility criteria and received at least one course of the planned treatment. The median time-to-treatment failure was 7.0 months. Twelve patients (33.3%) experienced adverse effects (AEs) >/= grade 3 and frequent AEs >/= grade 3, including neutropenia (22.2%) and neuropathy (13.9%). Hypertension was the most frequent AE >/= grade 3 associated with bevacizumab (11.1%). Low baseline creatinine clearance associated significantly with the incidence of AEs >/= grade 3. Response and disease control rates were 55.6 and 91.7%, respectively. Median progression-free and overall survival times were 11.7 months (95% confidence interval, 8.0-13.4 months) and 22.9 months, respectively. CONCLUSION: XELOX combined with bevacizumab was well tolerated by selected Japanese patients aged >/= 75 years with mCRC patients, and controlled clinical trials are now required to determine the survival benefit. FAU - Munemoto, Yoshinori AU - Munemoto Y AD - Department of Surgery, Fukuiken Saiseikai Hospital, Fukui, Japan. Y-MUNEMOTO@fukui.saiseikai.or.jp. FAU - Kanda, Mitsuro AU - Kanda M AD - Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. m-kanda@med.nagoya-u.ac.jp. FAU - Ishibashi, Keiichiro AU - Ishibashi K AD - Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. k_ishi@saitama-med.ac.jp. FAU - Hata, Taishi AU - Hata T AD - Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. thata@gesurg.med.osaka-u.ac.jp. FAU - Kobayashi, Michiya AU - Kobayashi M AD - Department of Human Health and Medical Sciences, Kochi Medical School, Kohasu, Japan. kobayasm@kochi-u.ac.jp. FAU - Hasegawa, Junichi AU - Hasegawa J AD - Department of Surgery, Osaka Rosai Hospital, Sakai, Japan. j-hasegawa@orh.go.jp. FAU - Fukunaga, Mutsumi AU - Fukunaga M AD - Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan. fukunaga1404@hp.pref.hyogo.jp. FAU - Takagane, Akinori AU - Takagane A AD - Surgical Division, Hakodate Goryoukaku Hospital, Hakodate, Japan. takagane@gobyou.com. FAU - Otsuji, Toshio AU - Otsuji T AD - Department of Internal Medicine, Dongo Hospital, Yamatotakada, Nara, Japan. hxgcd792@yahoo.co.jp. FAU - Miyake, Yasuhiro AU - Miyake Y AD - Department of Surgery, Minoh City Hospital Gastrointestinal Research Center, Minoh, Osaka, Japan. hotymiyake@hotmail.com. FAU - Nagase, Michitaka AU - Nagase M AD - Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan. mnagase@nagoya-1st.jrc.or.jp. FAU - Sakamoto, Junichi AU - Sakamoto J AD - Director, Tokai Central Hospital, Gifu, Japan. sakamjun@med.nagoya-u.ac.jp. FAU - Matsuoka, Masaki AU - Matsuoka M AD - Matsuoka Clinic, Kitakatsuragi, Nara, Japan. masa2722@mac.com. FAU - Oba, Koji AU - Oba K AD - Department of Biostatistics, School of Public Health, Tokyo University Graduate School of Medicine, Tokyo, Japan. oba@epistat.m.u-tokyo.ac.jp. AD - Interfaculty Initiative in Information Studies, Tokyo University, Tokyo, Japan. oba@epistat.m.u-tokyo.ac.jp. FAU - Mishima, Hideyuki AU - Mishima H AD - Unit of Cancer Center, Aichi Medical University, Nagakute, Japan. hmishima@aichi-med-u.ac.jp. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20151024 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Organoplatinum Compounds) RN - 04ZR38536J (Oxaliplatin) RN - 2S9ZZM9Q9V (Bevacizumab) RN - 6804DJ8Z9U (Capecitabine) SB - IM MH - Age Factors MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage MH - *Asian People MH - Bevacizumab/*administration & dosage/adverse effects MH - Capecitabine/*administration & dosage/adverse effects MH - Colorectal Neoplasms/*diagnosis/*drug therapy/mortality MH - Female MH - Humans MH - Male MH - Nausea/chemically induced MH - Neutropenia/chemically induced MH - Organoplatinum Compounds/*administration & dosage/adverse effects MH - Oxaliplatin MH - Prospective Studies MH - Survival Rate/trends MH - Treatment Outcome PMC - PMC4619505 EDAT- 2015/10/27 06:00 MHDA- 2016/08/19 06:00 PMCR- 2015/10/24 CRDT- 2015/10/27 06:00 PHST- 2015/01/22 00:00 [received] PHST- 2015/10/08 00:00 [accepted] PHST- 2015/10/27 06:00 [entrez] PHST- 2015/10/27 06:00 [pubmed] PHST- 2016/08/19 06:00 [medline] PHST- 2015/10/24 00:00 [pmc-release] AID - 10.1186/s12885-015-1712-0 [pii] AID - 1712 [pii] AID - 10.1186/s12885-015-1712-0 [doi] PST - epublish SO - BMC Cancer. 2015 Oct 24;15:786. doi: 10.1186/s12885-015-1712-0.